Investigation of Outpatient PUlmonary REhabilitation in Patients Suffering From Post-PE Syndrome: a Randomized Waitlist-controlled Trial - the PURE-PE Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- 6-Minute Walk Test
研究概览
简要总结
This study is a multicenter, parallel, randomized waitlist-controlled trial that primarily focuses on the short-term benefit of outpatient pulmonary rehabilitation (PR) on patients after acute pulmonary embolism.
Patients will be randomized into an intervention and a control group. The intervention group will receive 6 weeks of outpatient PR, while patients in the other treatment arm will serve as a control. After completion of the randomized study, the second arm will undergo PR as well.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
As the control group will undergo rehabilitation after the study period as well, it is possible to blind patients and outcome assessors to the treatment group.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Post-PE syndrome (except patients previously diagnosed with CTEPH) diagnosed by any of the following:
- •Post-PE functional impairment criteria
- •Post-PE Cardiac Impairment criteria
- •Chronic Thromboembolic Disease criteria
- •Possibility of starting rehabilitation between 12 and 36 weeks after the initial event of PE
排除标准
- •CTEPH diagnosis
- •Chronic pulmonary diseases: COPD, interstitial lung diseases, asthma (only patients with severe asthma defined as a FEV1 ≤ 80% will be excluded), a statement on COVID-19 was amended due to the pandemic #
- •Active cancer
- •Pregnancy
- •Myocardial infarction or cardiac surgery one year prior to inclusion
- •Congenital heart disease, congestive heart failure
- •History of stroke
- •Any previous inpatient or outpatient PR
- •Additional criteria that are absolute contraindications for pulmonary rehabilitation
- •Acute and decompensated disease states with severe functional restrictions of various organ systems (e.g. heart, kidney and liver insufficiency, unstable angina pectoris, hemodynamically unstable arrhythmias, acute spinal cord injury, untreated hormonal disorders, acute psychological disorders)
- •open tuberculosis
- •active infectious diseases and acute inflammatory processes
- •Stressful and time-consuming therapy that significantly impair the ability to rehabilitate (e.g. chemotherapy or radiation therapy after malignancy)
- •Participants who are not sufficiently resilient due to physical or mental impairment and / or cannot be mobilized and therefore cannot actively use the rehabilitation facility
- •lack of motivation for therapy
- •massive incontinence
- •drugs and alcohol addiction
研究组 & 干预措施
Intervention
Patients will undergo 6 weeks of outpatient rehabilitation.
干预措施: Rehabilitation (Other)
Control
Patients will receive no intervention throughout the 6 weeks period.
结局指标
主要结局
6-Minute Walk Test
时间窗: within the 6-week study period
change of walking distance covered within 6 minutes before and after the intervention/control period, measured in meters
次要结局
- One-repetition maximum for lower extremities(within the 6-week study period)
- Maximal workload(within the 6-week study period)
- Maximal inspiratory muscle pressure(within the 6-week study period)
- One-repetition maximum for upper extremities(within the 6-week study period)
- peak oxygen consumption(within the 6-week study period)
- Inspiratory muscle endurance(within the 6-week study period)
- Level of dyspnea(within the 6-week study period)
- Health related quality of life(within the 6-week study period)
- Disease related quality of life(within the 6-week study period)
- Anxiety and depression(within the 6-week study period)
- Functional limitations(within the 6-week study period)
- Functional status(within the 6-week study period)
研究者
Stephan Nopp
Principal investigator
Medical University of Vienna